NIOX MINO - Warning; Intended Use (Europe); Training Requirements

2
Warning!
• Handle the NIOX MINO
®
instrument as
statedinthismanual.Circassiaacceptsno
responsibilityfordamagedequipmentor
faultyresultsiftheequipmentisnothandled
accordingtothismanual.
•DonotuseadamagedNIOXMINOinstrument
ordamagedcomponents.
•Useonlythepowersupplyunitprovided.
•Keeptheinstrumentoutofwater.Ensure
thatnoliquidisspilledordrippedonthe
instrument.
• Do not heat or dispose of the instrument or
Sensorinre.Pleaserefertothe"Disposalof
used/expiredproducts"section.
•Takecarenottodroptheinstrumentorsubject
ittostrongimpact.
• It is recommended not to use NIOX MINO
intheproximityofareaswherevolatile
substancessuchasorganicuidsor
disinfectantsarebeingused.Specialattention
should be paid to aerosols and disinfection
baths(eitheropenvesselsorultrasonicbaths).
• NIOX MINO should not be used adjacent to or
stackedwithotherequipment.
•TheNIOXMINOSensorcontainschemicals
thatcouldbeharmfulifswallowed.
•Touchonlythegreycapwhenexchangingthe
Sensor.
•DonotcleantheSensor.Cleaningofthe
Sensorwithethanolorsimilardisinfectant
mightdestabilizeitforanon-predictabletime
period.
•KeeptheSensoroutofwater.Ensurethatno
liquidisspilledordrippedontheSensor.
•TheNOscrubbercontainspotassium
permanganateandshouldbedisposedofas
hazardouswasteinaccordancewiththelocal
wastedisposalregulations.
• Whenselectinganaccessoryforyour
NIOX MINO please keep in mind that an
accessorynotrecommendedbyCircassia
mayresultinlossofperformance,damageto
yourNIOXMINO,re,electricshock,injury
ordamagetootherproperty.Theproduct
warrantydoesnotcoverproductfailureor
damageresultingfromusewithnon-approved
accessories.Circassiatakesnoresponsibility
for health and safety problems or other
problems caused by the use of accessories
notapprovedbyCircassia.
•NomodicationoftheNIOXMINOinstrument
ortheSensorisallowed.
Also see Cautions page 19.
Intended use (Europe)
NIOX MINO
®
AirwayInammationMonitor
measuresFractionalExhaledNitricOxide(FeNO)
inhumanbreath.ThelevelofNitricOxideis
elevatedwheneosinophilicairwayinammation
ispresentanddecreasesasaresponsetoanti-
inammatorytreatment.TheFeNO concentration
in expired breath can be measured by NIOX MINO
withassurancethatsuchmeasurementsare
repeatableandaccordingtoguidelinesforNO
measurement established jointly by the European
RespiratorySocietyandtheAmericanThoracic
Society
1
.
Measurement of FeNO by NIOX MINO is a
quantitative,non-invasive,simpleandsafemethod
to measure the FeNO concentration in patients
withasthma-likeairwaysymptomsinorderto
establish and monitor the presence of eosinophilic
airwayinammation.
NIOXMINOissuitableforchildren,approximately
4-17years,andadults18yearsandolder.
FeNO measurements should be used as part
oftheregularassessmentandmonitoringof
asthma patients to improve the patient’s asthma
management.NIOXMINOshouldbeused
asdirectedintheNIOXMINOUserManual.
NIOXMINOmaynotbeusedwithinfantsorby
childrenapproximatelyundertheageof4,as
measurementrequirespatientcooperation.
1
Am J Respir Crit Care Med 2005; 171: 912-930.
Training requirements
NIOX MINO should only be used as directed in this
manual,bytrainedphysicians,nurses,respiratory
therapistsandlaboratorytechnicians.“Trained”
statusisachievedonlyaftercarefulreadingofthis
manual.